Color Stability of NeoMTA Pulpotomized Primary Teeth

NCT ID: NCT03254290

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-06-30

Brief Summary

This randomized control study will use 15 pediatric subjects selected from the patient population in the pediatric dental clinic at Children's Medical Center Dental Clinic (CMC Dental Clinic). The study will use a within-subject control design whereby one tooth will be treated with a pulpotomy using the new formulation of MTA (NeoMTA Plus, Avalon Biomed Inc., Bradenton, FL, USA) and restored with a multi-surface composite, and the other tooth with a formocresol pulpotomy and restored with a multi-surface composite; thus, approximately 15 teeth will be treated for each treatment group. The specific treated tooth will be randomized as to which side will receive the MTA or formocresol using sealed, opaque envelopes. Approximately 15 subjects will be needed for the study in order to elicit any significant findings as demonstrated by a power analysis.

Detailed Description

Each of the 15 patients will represent a pair of teeth. Within a given patient, assignment of the first tooth to either treatment will be determined randomly by selecting a sealed, opaque envelope with a designated treatment, with another tooth being assigned to the other treatment. All patients must demonstrate sufficient cooperation for treatment and follow-up radiographs. All procedures, possible risks or discomforts, in addition to possible benefits will be explained to the parents of all patients involved, and informed consent will be obtained from each parent.

The goal will consist of completing all treatment in one appointment; however, in the event that all treatment is unable to be completed, for example, local anesthetic limitations, the patient will be scheduled for the next available appointment, keeping them as close together as possible.

Patients will be anesthetized with local anesthesia, and treatment will be performed utilizing rubber dam isolation. The pulpotomy procedure will include removal of the carious tooth structure using a high-speed carbide bur and water spray. When the removal of carious tooth structure results in pulp exposure, the roof of the chamber will be removed. A high-speed handpiece and sterile spoon excavator will be used to remove the coronal pulp tissue. The amputation site will be cleaned and hemostasis obtained with a wet cotton pellet. The site will then be treated with either a slurry of NeoMTA Plus according to the manufacturer's directions or traditional Formocresol according to the manufacturer's directions. The remaining pulp chamber will be filled with a visible light cured resin-reinforced glass ionomer and will then receive a multi-surface composite final restoration

Conditions

Dental Caries Extending to Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental NeoMTA

The new formulation of MTA (does not contain bismuth oxide) will be used in one tooth receiving a pulpotomy to determine if the color of the tooth changes over time.The new formulation has received the FDAs 510(k) substantial equivalence clearance for Class II dental materials and is equivalent to its MTA predicate (ProRoot, Dentsply Tulsa Dental, Tulsa, OK, USA).

Group Type: EXPERIMENTAL

NeoMTA

Intervention Type: BIOLOGICAL

A new formulation of MTA was developed in which bismuth oxide was omitted.

Formocresol

Intervention Type: BIOLOGICAL

Control group

Formocresol

Control group. This group will receive the "gold standard" formulation of a formocresol pulpotomy.

Group Type: ACTIVE_COMPARATOR

Formocresol

Intervention Type: BIOLOGICAL

Control group

Interventions

NeoMTA

A new formulation of MTA was developed in which bismuth oxide was omitted.

Intervention Type: BIOLOGICAL

Formocresol

Control group

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Children between the ages of 2 ½ and 9 years of age and be ASA I or ASA II. Patient must have two, primary teeth that are matched for, size of carious lesion (same level of approximation of carious lesion to the pulp) and are that are treatment planned for a pulpotomy. The teeth selected for the study must be vital and asymptomatic both clinically and radiographically or only display symptoms consistent with reversible pulptitis The teeth selected for the study must be anticipated to be retained in the mouth for at least eighteen months

Exclusion Criteria

Teeth with a history of spontaneous pain. Teeth with radiographic evidence of internal or external resorption, intraradicular or periapical bone loss, loss of lamina dura, or widening of the periodontal ligament space

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A & M University Baylor College Of Dentistry

OTHER

Sponsor Role: lead

Responsible Party

Carolyn A. Kerins DDS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Related Links

http://www.accessdata.fda.gov/cdrh_docs/pdf14/K140955.pdf

Avalon Biomed Inc 2014

Other Identifiers

TexasAMBaylor

Identifier Type: -

Identifier Source: org_study_id